EN ISO 3826-1:2019

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.
This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2019)

Dieses Dokument legt Anforderungen einschließlich der geforderten Leistungsmerkmale fest für nicht belüftete, sterile Beutel (bekannt als Kunststoffbeutel), die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, integrierter Blutentnahmekanüle und wahlweise mit Überleitungsschlauch oder  schläuchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, zum Transport, zur Trennung und Verabreichung von Blut und Blutbestandteilen bestimmt sind. Die Kunststoffbeutel können, je nach vorgesehener Verwendung, Antikoagulans und/oder Stabilisatorlösungen enthalten.
Dieses Dokument ist auch anwendbar auf Mehrfachsysteme von Kunststoffbeuteln, die sich z. B. aus zwei, drei, vier oder mehr Einheiten zusammensetzen.
Soweit nichts anderes vorgegeben ist, gelten alle in diesem Dokument festgelegten Prüfungen für den gebrauchsfertigen Kunststoffbeutel.
Dieses Dokument gilt nicht für Kunststoffbeutel mit einem integrierten Filter.

Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches conventionnelles (ISO 3826-1:2019)

Le présent document spécifie les exigences, y compris les exigences de performance, des poches en plastique souple, sans prise d'air, stériles (appelées poches en plastique), présentées complètes avec tubulure de prélèvement à aiguille solidaire, raccord(s) de sortie, et, éventuellement, tubulure(s) de transfert, destinées au prélèvement, au stockage, au traitement, au transport, à la séparation et à la transfusion du sang et des composants du sang. Les poches en plastique peuvent contenir des solutions anticoagulantes et/ou de conservation, selon l'usage prévu.
Les exigences spécifiées dans le présent document sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans le présent document sont applicables aux poches en plastique prêtes à l'emploi.
Le présent document n'est pas applicable aux poches en plastique comportant un filtre intégré.

Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni vsebniki (ISO 3826-1:2019)

Ta dokument določa zahteve, vključno z zahtevami glede lastnosti, za plastične zložljive nezračene sterilne vsebnike (z drugim imenom plastične vsebnike) z izhodnimi priključki zbirne cevke, vdelano iglo in dodatnimi prenosnimi cevkami za odvzem, shranjevanje, obdelavo, transport, ločevanje ter dovajanje krvi in krvnih komponent. Plastični vsebniki lahko vsebujejo antikoagulant in/ali konzervans, odvisno od predvidene uporabe. Ta dokument se uporablja tudi za enote z več plastičnimi vsebniki, npr. za dvojne, trojne, četverne ali večje enote. Če ni navedeno drugače, se vsi preskusi, navedeni v tem dokumentu, uporabljajo za plastične vsebnike, pripravljene za uporabo. Ta dokument se ne uporablja za plastične vsebnike z vgrajenim filtrom.

General Information

• Status: Published
• Publication Date: 15-Oct-2019
• Withdrawal Date: 29-Apr-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Oct-2019
• Completion Date: 16-Oct-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 3826-1:2019 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

Relations

• Replaces: EN ISO 3826-1:2013 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
• Effective Date: 10-Feb-2016
• Amended By: EN ISO 3826-1:2019/A1:2023 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
• Effective Date: 08-Dec-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2019
Nadomešča:
SIST EN ISO 3826-1:2013
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni
vsebniki (ISO 3826-1:2019)
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2019)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2019)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2019)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 3826-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 3826-1:2013
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2019)
Poches en plastique souple pour le sang et les Kunststoffbeutel für menschliches Blut und
composants du sang - Partie 1: Poches Blutbestandteile - Teil 1: Konventionelle Beutel (ISO
conventionnelles (ISO 3826-1:2019) 3826-1:2019)
This European Standard was approved by CEN on 25 August 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 3826-1:2019) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 3826-1:2013.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 3826-1:2019 has been approved by CEN as EN ISO 3826-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 3826-1
Third edition
2019-09
Plastics collapsible containers
for human blood and blood
components —
Part 1:
Conventional containers
Poches en plastique souple pour le sang et les composants du sang —
Partie 1: Poches conventionnelles
Reference number
ISO 3826-1:2019(E)
©
ISO 2019
ISO 3826-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 3826-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 2
5 Design . 2
5.1 General . 2
5.2 Air content . 3
5.3 Emptying under pressure . 3
5.4 Pilot samples . 3
5.5 Rate of collection . 3
5.6 Collection and transfer tube(s) . 5
5.7 Blood-taking needle . . 6
5.8 Outlet port(s) . 6
5.9 Suspension . 7
6 Requirements . 7
6.1 General . 7
6.2 Physical requirements . 7
6.2.1 Conditions of manufacture . 7
6.2.2 Sterilization . 7
6.2.3 Transparency . 7
6.2.4 Coloration . 8
6.2.5 Thermal stability. 8
6.2.6 Water vapour transmission . 8
6.2.7 Resistance to leakage . 8
6.2.8 Particulate contamination . 8
6.3 Chemical requirements. 9
6.3.1 Requirements for the raw container or sheeting. 9
6.3.2 Requirements for the test fluid . 9
6.4 Biological requirements .10
6.4.1 General.10
6.4.2 Impermeability for microorganisms .10
6.4.3 Compatibility .10
7 Packaging .10
8 Labelling .10
8.1 General .10
8.2 Label on plastics container .11
8.3 Label on over-package .11
8.4 Label on shipping box .12
8.5 Label requirements .12
9 Anticoagulant and/or preservative solution .12
Annex A (normative) Chemical tests .13
Annex B (normative) Physical tests .
...